Sanofi Aventis Korea said Tuesday that it was launching a hemophilia A treatment, Eloctate (ingredient: efmoroctocog-alfa), in an online news conference.
Eloctate is a drug with fragment crystallizable (Fc) fusion protein that has a 1.5 times extended half-life compared to traditional treatments. It was developed by linking blood coagulation factor to the Fc protein to treat hemophilia A.
The company said it minimized the interval between doses compared to that of the existing hemophilia A treatment by increasing the half-life.
Hemophilia A is a genetic disorder caused by missing or defective coagulation factor 8, a blood-clotting protein.
|Professor Park Young-sil of the Kyung Hee University Hospital at Gangdong speaks during an online conference for the launch of Sanofi Aventis Korea’s hemophilia A treatment Eloctate on Tuesday.|
According to Professor Park Young-sil of Kyung Hee University Hospital at Gangdong, the standard treatment is to intravenously inject 25 to 40 international units per kilogram of the coagulation factor three times a week. However, the treatment compliance is low and pediatric patients have difficulty injecting due to frequent administration, he noted.
The efficacy of Eloctate was confirmed in phase 3 clinical trials, A-LONG, Kids A-LONG, and the extension study called ASPIRE.
The ASPIRE study is an open-label, non-randomized study on 150 and 61 severe hemophilia A patients who participated in A-LONG and Kids A-LONG studies.
In the results of the extended study, ASPIRE, Eloctate continued to improve joint condition until the second year of administration regardless of the injection interval.
Of the 235 target joints in adult patients in the A-LONG, 99.18 percent of the cases were resolved. Also, all nine target joints occurred in the Kids A-LONG study were relieved.
In particular, the therapeutic effect was most visible in patients who were in the group of lower 25 percent of joint condition severity at the beginning of the A-LONG study.
During the research period, no neutralizing antibodies to blood clotting factor eight and anaphylaxis reactions were detected in A-LONG and Kids A-LONG. Neutralizing antibodies were also not found during the four years of ASPIRE study, the company said.
|Sanofi Aventis Korea’s hemophilia A drug, Eloctate|
“We would introduce hemophilia A treatment, Elocate, in addition to hemophilia B treatment, Alprolix, which was released in March,” Sanofi Genzyme CEO Park Hee-kyung said. “This means that Sanofi, which has provided innovative solutions to rare diseases, can also positively contribute to hemophilia treatment.”